PROFILE |
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7+
years of consulting experience in pharmaceutical product
development (CMC, GMP) for biomedical companies |
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15+
years experience in pharmaceutical/biotech
product development |
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Planning
and implementation of analytical/formulation/manufacturing
strategies for new drugs, drug delivery systems and imaging
agents |
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Organization
and leadership of project teams |
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Setup
of R&D Departments in startup companies (labs, equipment,
and staff) |
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Management
of contract manufacturers and contract laboratories |
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Analytical
assay design, implementation, validation, troubleshooting |
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GMP
manufacturing and process validation |
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Preparation
of SOPs, manufacturing documents and QC documents for
regulatory filings |
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FDA preapproval inspection and meetings |
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Products
developed: |
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On
Market: Doxil® (cancer), Amphocil® (systemic antifungal),
Gadolite® Oral (MRI contrast agent)
Phase II, III: Motexafin gadoliniumTM (cancer)
Phase I: Motexafin lutetiumTM (cancer and cardiovascular
disease), TransfersulinTM (diabetes) |
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WORK
EXPERIENCE |
| Lang
Consulting, Inc., Fremont, CA |
1999-present |
| Consultant
|
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Strategic
and scientific/technical product development consulting
services to the Biomedical Industry
Works with clients to develop and implement strategies
for product manufacturing and testing in compliance with
FDA regulations through |
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Design
and execution of strategies for formulation, product manufacturing,
quality control, product stability assessments and validation
studies (CMC) |
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Planning,
execution and documentation of and assay (test method)
development and manufacturing process validation studies
(ICH guidelines) |
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Design/review
of test methods, manufacturing documents and other GMP
documentation |
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Managing
GMP manufacturing, process validation, QC testing by contract
manufacturers/laboratories |
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Directing
test method development and validation projects |
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Directing
external R&D laboratory projects and multidisciplinary
teams made up of client company employees and contractors |
|
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| IDEA
GmbH, Muenchen, Germany |
1997-1998 |
| Director,
Product Development |
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| Responsible
for all product development activities in startup company
developing transdermal peptide and protein delivery systems,
including |
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Setup
and validation of appropriate release/stability assays
for manufacturing QC |
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Validation
of bioanalytical assays supporting preclinical/clinical
studies in contract laboratories |
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Small
scale GMP manufacturing of Phase I clinical supplies |
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Technology
transfer to/from corporate partners |
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Leading project teams |
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Presentations
to Board and Investors |
|
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| Pharmacyclics,
Inc., Sunnyvale, CA |
|
| Director,
Analytical Chemistry |
1993-1994 |
| Director
of Analytical and Pharmaceutical Sciences |
1994-1996 |
Directed
R&D functions for new chemical entities (product candidates
for
oncology and cardiovascular therapies) including: |
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Analytical
and bioanalytical assay development, validation and QC
transfer |
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Formulation
development |
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Process
development and transfer to contract manufacturers |
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Manufacturing
of clinical supplies |
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Preparation
of GMP documents and documents for regulatory submissions
(IND, NDA) and FDA preapproval inspection |
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Established
and managed Analytical Chemistry and Formulation Development
Departments (lab design, equipment, and staff) |
|
Planned and implemented analytical testing for new drug
candidates |
|
Directed
bioanalytical assay development and validation in contract
laboratories |
|
Led
project team developing first company product (oral MRI
imaging agent) |
|
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| Liposome
Technology, Inc., Menlo Park, CA |
|
| Scientist |
1987-1990 |
| Senior
Scientist |
1990-1993 |
Established
and directed Analytical Development Group of the company.
Developed, validated and implemented analytical and bioanalytical
assays such as: |
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Release- and stability testing of liposomal drugs and
lipid carriers |
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In-process testing |
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Pharmacokinetics
and biodistribution |
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Designed
and implemented Standard Operating Procedures for assay
validation and QC transfer |
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Designed
and implemented novel approaches for analysis of liposomal
drugs and raw materials |
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Developed
and evaluated prototype liposome drug formulations (small
molecules, peptides, proteins) |
|
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| University
of California, Berkeley, CA |
1985-1987 |
| Postdoctoral
Fellow, Department of Physiology |
|
| Collaborated
with team researching effects of diet and exercise on
in vivo lipidperoxidation |
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Isolated
functional purified rat liver subcellular fractions |
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Developed
quantitative assays to measure antioxidants in tissues,
cell isolates and subcellular fractions by chromatography
with UV and electrochemical detection. |
|
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| University
of Graz, Austria |
1982-1985 |
|
Postdoctoral Fellow, Department of Biochemistry |
|
| Studied
oxidation of cell membrane lipids (lipidperoxidation)
|
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Developed
quantitative assays for determination of lipidperoxidation
products by
HPLC, GC, TLC and solid phase extraction |
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Determined
metabolism and reactivity of lipidperoxidation products
with biomolecules |
|
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EDUCATION |
BS
in Business Administration, Business College Salzburg, Austria
(1974)
PhD in Chemistry, University of Graz, Austria (1982)
MBA graduate course "Management and organizational behavior",
Golden Gate University (1996) |
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PROFESSIONAL
ACTIVITIES |
| Ad
hoc reviewer: Journal of Chromatography, Analytical Biochemistry |
| Editorial
Board: CRC Focus on Membrane Lipid Oxidation |
| Associations:
American Association of Pharmaceutical Scientists, Regulatory
Affairs Professionals Society, San Francisco Bay Area Biomedical
Consultants Network |
| Offices
held: Secretary, American Women in Science, Program Chair, Chair-elect,
Chair, NCPDG 1990-1994, Program Committee Western Regional AAPS
meeting 1996, 1997 |
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HONORS
AND AWARDS |
| Promotio
sub auspiciis praesidentis (1983) |
| Schroedinger
Postdoctoral Fellowship Award (1985) |
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| PUBLICATIONS |
| 30
+ peer reviewed journal publications and book chapters. Publication
list available on request. |
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